Anhui Double-Crane secures NMPA approval for potassium chloride injection expansion

Anhui Double-Crane Pharmaceutical Co., Ltd., a wholly-owned subsidiary of China Resources Double-Crane Pharmaceutical Co., Ltd., has received a supplementary drug application approval for its potassium chloride injection (10ml:1.5g) from the National Medical Products Administration (NMPA). This approval includes a new strength and successfully passed the quality and efficacy consistency evaluation for generic drugs. The company initiated research for this new strength in June 2023, with the application submitted in August 2024 and approval granted on August 25, 2025.

The total research and development investment for this potassium chloride injection by Anhui Double-Crane amounted to CNY 1,610,900. Potassium chloride injection is used for treating and preventing hypokalemia when oral administration is not possible. Global sales of potassium chloride injection reached $223m in 2024.

In the domestic market, there are 44 manufacturers of 10ml:1.5g potassium chloride injection, with 26 having passed or being deemed to have passed the consistency evaluation. Total sales of potassium chloride injection in the Chinese medical and retail markets in 2024 were CNY 617m. Anhui Double-Crane’s potassium chloride injection generated CNY 960,000 in sales revenue in 2024. This approval is expected to enhance future market competitiveness and inform subsequent generic drug consistency evaluations.